Prasugrel Teva 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Prasugrel Teva 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Prasugrel Teva is and what it is used for
2. What you need to know before taking Prasugrel Teva
3. How to take Prasugrel Teva
4. Possible side effects
5. How to store Prasugrel Teva
6. Contents of the pack and other information

1. What Prasugrel Teva is and what it is used for

Prasugrel Teva contains the active substance prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells. When a blood vessel is damaged, for example by a cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. However, the formation of clots in hardened blood vessels, such as arteries, can be very dangerous because they block the flow of blood, leading to a heart attack (myocardial infarction), stroke, or death. Clots in arteries supplying blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel Teva inhibits platelet aggregation, thereby reducing the likelihood of blood clot formation.

Your doctor has prescribed Prasugrel Teva because you have had a myocardial infarction or unstable angina and have been treated with a procedure to open blocked heart arteries. You may have had one or more stents placed in the blocked or narrowed artery to restore blood flow to the heart. Prasugrel Teva reduces the risk of future heart attacks or strokes, or of dying from such atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

2. What you need to know before starting to take Prasugrel Teva

Do not take Prasugrel Teva:

• If you are allergic to prasugrel or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present as a skin rash, itching, facial swelling, swelling of the lips, or difficulty breathing. If this has occurred, consult your doctor immediately.
• If you have a medical condition causing bleeding, such as stomach or intestinal bleeding.
• If you have ever had a stroke or a transient ischemic attack (TIA).
• If you have severe liver disease.

Warnings and precautions

• Before taking Prasugrel Teva:

Talk to your doctor or pharmacist before starting Prasugrel Teva if any of the following apply to you:

• If you are at high risk of bleeding because:

  • you are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg, as patients over 75 years have an increased risk of bleeding
  • you have recently suffered a serious injury
  • you have recently undergone surgery (including certain dental procedures)
  • you have recently or repeatedly experienced stomach or intestinal bleeding (e.g. a stomach ulcer or colon polyps)
  • you weigh less than 60 kg. In this case, your doctor should prescribe a daily dose of 5 mg of prasugrel
  • you have kidney disease or moderate liver problems
  • you are taking other medicines (see “Use with other medicines”)
  • you are scheduled to undergo surgery (including certain dental procedures) within the next seven days. Your doctor may instruct you to temporarily stop treatment with prasugrel due to an increased risk of bleeding.

• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, please inform your doctor before starting treatment with prasugrel. If, after taking Prasugrel Teva, you experience an allergic reaction such as rash, itching, facial swelling, swelling of the lips, or difficulty breathing, contact your doctor immediately.

• While taking Prasugrel Teva:

You must contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising (bruises) under the skin appearing as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).

Children and adolescents

Prasugrel Teva must not be used in children or adolescents under 18 years of age.

Use of Prasugrel Teva with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, dietary supplements, or herbal products. It is especially important to inform your doctor if you are being treated with clopidogrel (an antiplatelet agent), warfarin (an anticoagulant), or non-steroidal anti-inflammatory drugs (NSAIDs) for pain and fever (such as ibuprofen, naproxen, etoricoxib). When taken together with prasugrel, these medicines may increase the risk of bleeding.

Inform your doctor if you are taking morphine or other opioids (used to treat acute pain).

Only take other medicines while taking Prasugrel Teva if your doctor has instructed you that it is safe to do so.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, consult your doctor before using this medicine. You should take prasugrel only after discussing with your doctor the potential benefits and any possible risks to the fetus.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Prasugrel Teva is unlikely to affect your ability to drive or operate machinery.

Prasugrel Teva contains saccharose stearate

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Prasugrel Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg once daily. Your treatment will start with a single 60 mg dose.

If your body weight is less than 60 kg or you are over 75 years of age, the dose is 5 mg of prasugrel daily. Your doctor will also instruct you to take acetylsalicylic acid and will specify the exact dose you should take (usually between 75 mg and 325 mg daily).

You may take Prasugrel Teva with or without food. Take your dose at approximately the same time each day.

The tablet may be divided into equal doses. Do not crush the tablet.

It is important that you inform your doctor, dentist, and pharmacist that you are taking Prasugrel Teva.

If you take more Prasugrel Teva than you should

Contact your doctor or hospital immediately, as you may be at risk of excessive bleeding. You should show your doctor the Prasugrel Teva packaging.

If you forget to take Prasugrel Teva

If you forget to take your scheduled daily dose, take prasugrel as soon as you remember. If you forget to take your dose for an entire day, resume your usual dose of Prasugrel Teva the next day. Do not take a double dose to make up for missed doses.

If you stop taking Prasugrel Teva

Do not stop your treatment without consulting your doctor. If you stop treatment with Prasugrel Teva too early, your risk of having a myocardial infarction may increase.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following signs:

• • Sudden numbness or weakness of the arm, leg, or face, especially if it affects only one side of the body.
• Sudden confusion, difficulty speaking or understanding others.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe dizziness or headache without a known cause.

All of these may be signs of a stroke. Stroke is an uncommon adverse effect of prasugrel in patients who have never previously had a stroke or a transient ischaemic attack.

You should also contact your doctor immediately if you notice any of the following signs:

• Fever and bruising (haematomas) under the skin appearing as localized red spots, with or without unexplained extreme tiredness, confusion, or yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before taking Prasugrel Teva”).
• A rash, itching, or swelling of the face, swelling of lips/tongue, or difficulty breathing. These may be signs of a serious allergic reaction (see section 2 “What you need to know before taking Prasugrel Teva”).

Inform your doctor promptly if you experience any of the following signs:

• Blood in urine.
• Rectal bleeding, blood in stools, or black stools.
• Uncontrolled bleeding, for example after a cut.

All of these may be signs of bleeding, the most common adverse effect with prasugrel. Although uncommon, serious bleeding can be fatal.

Common adverse effects (may affect up to 1 in 10 people)

• Bleeding in the stomach or intestine
• Bleeding at the site of needle injection
• Nosebleeds
• Skin rash
• Small red spots on the skin (ecchymosis)
• Blood in urine
• Haematoma (bleeding under the skin at the injection site or in a muscle, causing swelling)
• Low haemoglobin or red blood cell count (anaemia)
• Bruising

Uncommon adverse effects (may affect up to 1 in 100 people)

• Allergic reaction (rash, itching, swelling of lips/tongue, or difficulty breathing)
• Spontaneous bleeding from the eye, rectum, gums, or in the abdominal area around internal organs
• Bleeding after surgery
• Bleeding when coughing
• Blood in stools

Rare adverse effects (may affect up to 1 in 1,000 people)

• Low platelet count in blood
• Subcutaneous haematoma (bleeding under the skin, causing swelling)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prasugrel Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prasugrel Teva

• The active substance is prasugrel (as prasugrel hydrobromide). Each film-coated tablet contains 10 mg of prasugrel (as prasugrel hydrobromide).
• The other ingredients are:

Core: microcrystalline cellulose, mannitol, hypromellose, low-substituted hydroxypropylcellulose, glycerol dibehenate and sucrose stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the pack

Prasugrel Teva 10 mg are beige, oval-shaped, film-coated tablets, marked with “P10” on one side and a score line on the other side.

Prasugrel Teva 10 mg is available in blister packs or unit-dose blisters containing 10, 14, 28, 28x1, 30, 30x1, 56, 84, 90, 90x1 and 98 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

Calle Anabel Segura, 11, Edificio Albatros, B 1st floor

Alcobendas 28108 Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Date of the most recent revision of the leaflet: May 2019

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)